Shed-Meds: A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy
Study Details
Study Description
Brief Summary
This randomized, controlled trial will evaluate the effects of an intervention to reduce exposure to medications among hospitalized older adults discharged to skilled nursing facilities (SNFs). The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences. The investigators will evaluate the effects of the intervention on the total number of medications prescribed to patients at hospital and SNF discharge and at home 90-days after SNF discharge along with the prevalence of eight geriatric syndromes, medication adherence, and health status.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
This randomized, controlled trial will evaluate the effects of an intervention to reduce exposure to medications among hospitalized older adults discharged to skilled nursing facilities (SNFs). This study will be conducted in one university-affiliated hospital and 14 area SNFs to enroll approximately 1,300 total participants across five project years. Patients discharged to SNF represent the largest segment of Medicare beneficiaries discharged to post-acute care services and are a particularly high risk group for loss of independence and other poor clinical outcomes. This investigative team recently completed a Centers for Medicare and Medicaid Services (CMS) Innovation Award, which provides strong preliminary data related to the prevalence of polypharmacy and the relationship between polypharmacy and geriatric syndromes (e.g., medications associated with falls) in this patient population. Based on these data, the investigators developed a structured deprescribing intervention protocol ("Shed-Meds") coupled with standardized screening assessments for eight geriatric syndromes to be implemented in the hospital and continued during the SNF stay. The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences. This trial will evaluate the effects of this intervention on medication exposure, medication adherence, geriatric syndromes, and health status across the care transitions from hospital to SNF to home to include a 90-day follow-up period after SNF discharge. The overarching hypothesis is that reducing medications for older patients across the continuum of care will favorably impact geriatric syndromes.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Shed-Meds: A Patient-Centered Deprescribing Intervention Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. |
Behavioral: Shed-Meds: A Patient-Centered Deprescribing Intervention
The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.
|
| No Intervention: Control Group Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified. |
Outcome Measures
Primary Outcome Measures
- Change in Total number of Medications [7, 60 and 90 days after discharge from the skilled nursing facility]
We will assess the change in the total number of prescribed medications
Secondary Outcome Measures
- Change in Functional Health Status [7 and 90 days after discharge from the skilled nursing facility]
We will use the Vulnerable Elders Survey (VES-13) as a functional measure of health status that assesses a patient's cognitive, physical and self-care activities and which also includes an item for self-rated health status
- Change in Drug Burden Index: Anticholinergic and sedative drug burden of prescribed medications [90 days after discharge from the skilled nursing facility]
The drug burden is the sum of each individual anticholinergic/sedative medication's prescribed daily dose divided by the sum of the minimum effective dose (as estimated by the FDA minimum recommended dose) and the patient's daily dose
- Change in Medication Adherence [60 and 90 days after discharge from the skilled nursing facility]
We will use the Adherence to Refills and Medication Scale (ARMS) to assess patients' medication adherence.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Hospitalized at Vanderbilt University Medical Center
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Medicare-eligible
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Discharged from VUMC to a post acute care facility
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Has polypharmacy as defined by > 5 medications
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Able to self-consent or has a proxy (surrogate)
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Speaks English (due to interview-based assessments)
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Primary home residence within one of 9 surrounding counties (due to home visit during follow-up phase)
Exclusion Criteria:
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Resides in long-term care
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Is currently on hospice or otherwise has a limited life expectancy (< 6 months).
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Enrolled in a clinical drug trial
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Has Stage IV Cancer Diagnosis
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Incarcerated or homeless
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Unable to self-consent and does not have a surrogate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37212 |
Sponsors and Collaborators
- Vanderbilt University Medical Center
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Sandra F Simmons, PhD, Vanderbilt University Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.- R01AG053264-01
- R01AG053264